Devlopment of Heart and blood vessel problems in patients with conditions which cause long-term, widespread, inflammation in the body.

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2007-005464-26-GB
• Date of registration: 11/04/2008
• Prospective Registration: Yes
• Primary sponsor: Kings College London
• Public title: Devlopment of Heart and blood vessel problems in patients with conditions which cause long-term, widespread, inflammation in the body.
• Scientific title: The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II - Inflammatory Biomarkers and Cardiovascular Function - Part II
• Date of first enrolment: 05/06/2008
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005464-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: Pre/post treatment- each subject is their own control; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: pre / post treatment - each subject is their own control; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Dr Valentina Puntmann
• Affiliation: Kings College London

• Name: Dr Valentina Puntmann
• Affiliation: Kings College London

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male and female subjects over 18 years of age
2. Systemic inflammatory conditions (rheumatoid arthritis) diagnosis established independently by the clinical team
3. Eligiblilty for anti-TNF-alpha therapy- decision to start treatment reached independently by the clinical team.
4.Woman of childbearing potential must have a negative serum pregnancy test within 7 days of the first adminstration of study treatment, and must be willing to use a reliable form of contraception to prevent pregnancy.
5. Provision of signed, informed, consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion criteria:
1. Inability to tolerate scanning (claustrophobia, inability to lie flat);
2. Contra-indications to MRI (implantable devices, hypersensitivity to Gadolinium-
containing contrast agents, weight over 120kg);
3. Inability to give informed consent;
4. Non-sinus rhythm;
5. Above 70 years of age.
6. Diagnosis of tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections, chronic infection or a history of recurrent infection.
7. Moderate or severe heart failure (NYHA class III/IV)
8. Patients with a history of hypersensitivity to infliximab, entanercept, adalimumab or other murine proteins, or to any of the excipients
9. Concomitant use of immunosuppressive therapy, anakinra, abatacept, sulfasalazine
or live vaccinations
10. Patient with a history of Hepatitis B and C virus infection
11. Patients with a history of malignancy
12. Significantly impaired renal function (eGFR >60 ml/min/1.73m2)
13. Significantly impaired hepatic function (alkaline transaminase twice above the upper limit of the normal range)
14. Pre-existing blood dyscrasias, such as significant marrow hypoplasia, leukopenia,
thrombocytopenia or anaemia
15. Current pregnancy or lactation.
16. Patients with any significant history of non-compliance to medical regimens.
17. History of asthma, significant bradycardia and arrhythmias
18. Known hypersensitivity to adenosine
19. Known or suspected bronchostrictive or bronchospasti disease
20. Second- or third- degree atrioventricular (AV) block, sinus bradychardia (heart rate <45 bpm)
21. Systemic arterial hypotension (<90mm Hg)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Rheumatoid Arthritis
MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870

Intervention(s)

Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 3-

Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 50-

Trade Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: Cimzia
Product Name: Cimzia
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Secondary Objective: Atherosclerotic plaque burden, Vascular distensibility and stiffness, Global and regional, systolic and diasystolic function and tissue characterisation, haematological and biochemical indices of vascular inflammation, myocardial microvascular function

Main Objective: To investigate TNF-alpha inhibitors altering cardiovascular function in patients with systemic inflammatory conditions (FMD, LV mass/LV volumes)

Primary end point(s): Primary Outcomes:
1. Aortic distensiblity and stiffness studies (PWV and AD)
2.Myocardial function (LV mass, LV volumes)

Timepoint(s) of evaluation of this end point: Prior to starting anti-TNF therapy and 3, 6, 18, months afterwards

Secondary Outcome(s)

Secondary end point(s): Secondary outcomes:
1.Atherosclerotic plaque burden
2.Global and regional, systolic and diastolic function and tissue characterisation
3.Myocardial microvascular function (coronary flow reserve)

Timepoint(s) of evaluation of this end point: Prior to starting anti-TMF therapy and 3, 6, 18, months afterwards

Secondary ID(s)

RECrefno07/H0707/114

Source(s) of Monetary Support

Guy's and St Thomas' NHS Foundation Trust BRC

Secondary Sponsor(s)

Guys and St Thomas'NHS Foundation Trust

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 26/04/2019
• Date Completed: 30/04/2014
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-005464-26/results